Thursday, Anglo-Swedish drug firm AstraZeneca plc (AZN AZN.L) announced that its anti-psychotic drugs Seroquel and Seroquel XR, the extended-release formulation have been approved in Europe for the treatment of major depressive episodes in bipolar disorder. Seroquel XR has also been cleared for the treatment of moderate to severe manic episodes in bipolar disorder in Europe.
Seroquel XR was approved to control depressive and manic symptoms of bipolar disorder in the U.S. last month.
AstraZeneca's Seroquel was originally approved by the FDA in 1997 to treat the symptoms of schizophrenia. In 2004, the company won FDA approval to expand use of Seroquel to treat mania associated with bipolar disorder.
The extended-release formulation, Seroquel XR was approved by the FDA in May 2007 for acute treatment of schizophrenia.
Seroquel is AstraZeneca's second-biggest selling drug next to heartburn drug Nexium. Seroquel that notched $4 billion in sales last year is the apple of discord between AstraZeneca and generic drug firm Teva Pharmaceutical Industries Ltd. (TEVA). The two companies are embroiled in a patent suit over Seroquel, which extends back to 2005.
Teva and generics unit of Novartis AG (NVS), Sandoz, filed Abbreviated New Drug Applications for 25 mg dosage of generic Seroquel in September 2005. AstraZeneca sued them alleging patent infringement as the patent covering Seroquel is scheduled to expire only in 2011.
In July of this year, the U.S. District Court for the District of New Jersey upheld AstraZeneca's valid intellectual property by granting its motion for summary judgment of 'No Inequitable Conduct' in the Seroquel patent litigation.
Teva and Sandoz had already conceded infringement and the validity of AstraZeneca's patent. Thus, only the inequitable conduct* contentions remained to be resolved. And with the court granting AstraZeneca summary judgment, the trial, which had been scheduled to begin on August 11, 2008, was called off. However, at that time Teva said that it would appeal the Court's ruling.
(* Inequitable conduct occurs when the patent holders makes affirmative misrepresentations of material facts related to their inventions and hold back any material information from the Patent Trade Office.)
On the London Stock Exchange, AZN.L is down 0.50% trading at 2,772 pence a share on a volume of 2.6 million shares.
AZN closed Wednesday's trade at $41.32 on the NYSE.
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